DELZICOL(mesalamine) delayed-release capsules
Generic Name and Formulations:
Mesalamine 400mg; del-rel caps.
Company:
Allergan
Select therapeutic use: Colorectal disorders
Indications for DELZICOL:
Mildly to moderately active ulcerative colitis (UC) in patients ≥5 years of age. Maintenance of remission of UC in adults.
Adult:
Swallow caps whole; if unable to swallow, may open and swallow contents (four 100mg tabs). Treatment: 800mg 3 times daily for 6 weeks. Maintenance: 1.6g/day in 2–4 divided doses. Two Delzicol 400mg caps are not bioequivalent to one mesalamine 800mg del-rel tab.
Children:
<5yrs: not established. Give twice daily dosing for 6 weeks. ≥5yrs (17–32kg): 36–71mg/kg/day, up to max 1.2g/day (800mg in the AM + 400mg in the afternoon); (33–53kg): 37–61mg/kg/day, up to max 2g/day (1200mg in the AM + 800mg in the afternoon); (54–90kg): 27–44mg/kg/day, up to max 2.4g/day (1200mg in the AM + 1200mg in the afternoon).
Warnings/Precautions:
Monitor renal function before and during therapy. History of renal disease. Conditions predisposing to myocarditis, pericarditis. Sulfasalazine allergy. Pre-existing liver disease. Upper GI tract obstruction. Reeva luate periodically. Elderly (monitor CBCs). Pregnancy (Cat.B). Nursing mothers.
Interactions:
Increased risk of renal reactions with nephrotoxic agents (eg, NSAIDs). Increased risk of blood disorders with azathioprine or 6-mercaptopurine.
Pharmacological Class:
Salicylate.
Adverse Reactions:
Abdominal pain, eructation, pain, headache, back pain, diarrhea, rash, dyspepsia, rhinitis, flu syndrome, asthenia, flatulence, vomiting, fever, arthralgia, constipation, GI bleeding; acute intolerance syndrome (discontinue if occurs), cardiac hypersensitivity reactions. Pediatrics: also, nasopharyngitis, sinusitis.
How Supplied:
Caps—180
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8e6b0544-e75d-463a-bd61-517834b49f53 |
